NCT06977633

Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes

A pH-Responsive Hydrogel Microneedle Patch for Continuous Measurement of Ketone Bodies and Glucose: CGM-CKM

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Mahla Poudineh · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate a CGM-CKM device during insulin suspension in patients with type 1 diabetes. 10 patients with T1D will be recruited for a pilot study. The patients will visit CTRU at Stanford Medical School. The CGM-CKM device will be applied to the upper arm area of patients and baseline ketone and glucose measurement will be performed for one hour prior to suspending or disconnecting the pump. Upon baseline measurement, the pump will be disconnected for 3 hours while the electrochemical signals are collected from the CGM-CKM device. During the 3 hours of pump disconnection, blood samples will be collected every 5 minutes from participants for analyzing their insulin and glucagon using conventional ELISA kits and glucose and ketone using standard meters.

Detailed description

This is a non-significant risk (NSR) device study not conducted under an IDE, in accordance with 21 CFR 812.2(b)

Conditions

• Type 1 Diabetes (T1D)

Interventions

Type	Name	Description
BEHAVIORAL	Temporary Insulin Suspension	Participants will suspend insulin delivery from their personal insulin pumps for up to 3 hours. Insulin suspension is temporary and participant-driven under supervision.
DEVICE	Glucose and ketone sensor	The participants wear a prototype continuous glucose-ketone monitoring (CGM-CKM) device using painless hydrogel microneedles for 4 hours.

Timeline

• Start date: 2025-08-30
• Primary completion: 2026-02-28
• Completion: 2027-04-30
• First posted: 2025-05-18
• Last updated: 2025-07-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study